Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Hospital Hietzing

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Drug: Cyclosporin; Drug: Hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT04597762

SiccaIkervis

Details and patient eligibility

About

Keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common ophthalmological diseases and is treated with tear substitutes to moisten the surface of the eye and, in more severe cases of this disease, with local anti-inflammatory therapy with corticosteroids or ciclosporin A. In patients with rheumatological diseases, such as Sjögren's syndrome, dry eye syndrome of severe extent occurs particularly frequently, which is why topical anti-inflammatory therapy is often necessary in these patients.

Aim of this study is to evaluate the treatment of severe dry eye syndrome with topical cyclosporin eyedrops with and without topical corticosteroids at the beginning of the treatment.

Enrollment: 12 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of severe keratoconjunctivitis sicca defined by:
• Staining of the cornea ≥ grade III according to the Oxford scale
• OSDI value ≥ 12
• Age between 18 and 90 years
• Primary or secondary Sjogren's syndrome (defined according to the American-European Consensus Group criteria) with a stable course and unchanged treatment for 6 months

Exclusion criteria

• Pregnancy (excluded with a pregnancy test in patients of childbearing potential)
• Children and young people up to the age of 18
• Eye surgery in the past 6 months
• Simultaneous participation in another study
• Regular use of eye drops, with the exception of tear substitutes
• Use of eye drops containing ciclosporin or glucocorticoids in the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone

Experimental group

Description:

Patients receive treatment with Ciclosporin eyedrops for the right eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the left eye

Treatment:

Drug: Hydrocortisone

Drug: Cyclosporin

left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone

Experimental group

Description:

Patients receive treatment with Ciclosporin eyedrops for the left eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the right eye

Treatment:

Drug: Hydrocortisone

Drug: Cyclosporin